Vice President, Healthcare Value

Sunday, August 24, 2014

One month and counting: Some UDI resources you may have missed

Today, we are just one month away from the first official US FDA UDI deadline: September, 24, 2014. That's when manufacturers of Class III devices must be in compliance with the US FDA rule. Over the years, GHX has been providing assistance to manufacturers to prepare for and now comply with the rule, not to mention making recommendations to hospitals and healthcare systems that ultimately must use the unique identifiers to achieve the vision of UDI. Below, I have posted a link to many of those blog posts, videos and articles. You can also find more at www.ghx.com/udi.

Today, we are just one month away from the first official US FDA UDI deadline: September, 24, 2014. That's when manufacturers of Class III devices must be in compliance with the US FDA rule. Over the years, GHX has been providing assistance to manufacturers to prepare for and now comply with the rule, not to mention making recommendations to hospitals and healthcare systems that ultimately must use the unique identifiers to achieve the vision of UDI. Below, I have posted a link to many of those blog posts, videos and articles. You can also find more at www.ghx.com/udi.

Just last week, GHX successfully completed submission of Class III product data to the FDA’s Global UDI Database (GUDID). We leveraged our relationship with PTC to submit the data in the required Health Level 7 Structured Product Label format to the GUDID.

2) Submitting the data to a staging environment to verify the data (and catch some formatting issues upfront)

3) Submitting the data to a test server at the FDA

4) Addressing issues identified by the FDA

5) Submitting the validated data to the FDA GUDID.

Last month’s call also highlighted the added complexities faced by manufacturers who are simultaneously trying to meet increasing demands from customers to provide UDI-like data through the Global Data Synchronization Network (GDSN). There are some important differences between the attributes in the GUDID and the GDSN and how they are populated. For those who may have missed the call, here is a link to the recording. Also, check out this blog post from Medical Design Technology.

As promised, here is a link to many of the resources we have produced over the years for providers and manufacturers alike: